Ignite Creation Date:
2025-12-24 @ 2:47 PM
Ignite Modification Date:
2026-03-04 @ 10:12 PM
Study NCT ID:
NCT00555659
Status:
COMPLETED
Last Update Posted:
2013-08-12
First Post:
2007-11-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Clinical Evaluation of the New Aegis Plate for Anterior Interbody Fusions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055009', 'term': 'Spondylosis'}, {'id': 'D013168', 'term': 'Spondylolisthesis'}, {'id': 'D003251', 'term': 'Constriction, Pathologic'}], 'ancestors': [{'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D013169', 'term': 'Spondylolysis'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 104}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-08-08', 'studyFirstSubmitDate': '2007-11-07', 'studyFirstSubmitQcDate': '2007-11-07', 'lastUpdatePostDateStruct': {'date': '2013-08-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-11-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intake data will include all fields traditionally associated with a detailed note. Subsequent visit instruments will include visual analog scale and oswestry disability index.', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Degeneration', 'Spondylosis', 'Spondylolisthesis', 'Stenosis'], 'conditions': ['Degeneration', 'Spondylosis', 'Spondylolithesis', 'Stenosis']}, 'descriptionModule': {'briefSummary': 'Introduction: Degenerative changes of the discs and facet joints in the lumbar spine can result in pain and disability from spondylosis, spondylolisthesis and stenosis. Patients who are suffering with back and/or leg pain are potential candidates for an ALIF procedure.\n\nPurpose: To assess and compare clinical outcomes and fusion rates in patients undergoing an instrumented ALIF procedure. Comparisons in all variables will be made across diagnostic categories. Comparisons between type of interbody spacer, graft type, and type of instrumentation will also be made', 'detailedDescription': 'To assess and compare clinical outcomes and fusion rates in patients undergoing an instrumented ALIF procedure. Comparisons in all variables will be made across diagnostic categories. Comparisons between type of interbody spacer, graft type, and type of instrumentation will also be made.\n\nThis study is part of a larger Continuous Quality Improvement initiative at the Columbia Orthopaedic Group. The purpose of this effort is to improve surgical and non-surgical outcomes by using rigorous statistical analysis of our outcomes to guide our treatment decisions. Through an iterative feedback process we hope to optimize patient outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Any person who comes into the clinic and gives consent to participate in this prospective study.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Standard of care\n\nExclusion Criteria:\n\n* Standard of care'}, 'identificationModule': {'nctId': 'NCT00555659', 'acronym': 'Aegis', 'briefTitle': 'Prospective Clinical Evaluation of the New Aegis Plate for Anterior Interbody Fusions', 'organization': {'class': 'OTHER', 'fullName': 'Columbia Orthopaedic Group, LLP'}, 'officialTitle': 'Prospective Clinical Evaluation of the New Aegis Plate for Anterior Interbody', 'orgStudyIdInfo': {'id': '1094241'}}, 'contactsLocationsModule': {'locations': [{'zip': '65201', 'city': 'Columbia', 'state': 'Missouri', 'country': 'United States', 'facility': 'Columbia Orthopaedic Group', 'geoPoint': {'lat': 38.95171, 'lon': -92.33407}}], 'overallOfficials': [{'name': 'John D Miles, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Columbia Orthopaedic Group, LLP'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Columbia Orthopaedic Group, LLP', 'class': 'OTHER'}, 'collaborators': [{'name': 'DePuy Spine', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Investigator', 'investigatorFullName': 'John Miles, MD', 'investigatorAffiliation': 'Columbia Orthopaedic Group, LLP'}}}}